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A Better Partnership


Sep 2015
September 11, 2015

FDA releases first two final rules under Food Safety Modernization Act

On Thursday, the U.S. Food and Drug Administration (FDA) released the first two final rules under the Food Safety Modernization Act (FSMA). The rules establish extensive new food safety requirements for all facilities that manufacture, process, pack or hold human or animal food products. Specifically, the rules require food facilities to:
  • Prepare and implement a food safety hazard control plan: Similar to the Hazard Analysis Critical Control Point (HACCP) plans already required for seafood and juice facilities, facilities manufacturing, processing, packing or holding any kind of human or animal food now must prepare comprehensive formal written safety plans that analyze hazards and institute controls to prevent such hazards.
  • Comply with new Current Good Manufacturing Practices (CGMPs): The CGMPs for human food facilities have been revised and modernized. And, for the first time, animal food facilities must also now comply with specified CGMPs.
The deadlines listed below for compliance with the new rules are determined by the size of the facility and begin to run from the date of publication of the final rules. The rules will not be formally published until September 17, 2015.
  • Businesses averaging less than $1 million per year annual sales, and any businesses subject to the Pasteurized Milk Ordinance: Three years.
  • Businesses with fewer than 500 full-time employees: Two years.
  • Businesses with more than 500 full-time employees: One year.
Links to the new rules are below:
If you have questions about the new FSMA regulations or other food regulatory questions, please contact Chris Predko (616.752.2190 or

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